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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The PBT assessment for 2,5-Xylenol (CAS 95-87-4) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

Persistence

The substance 2,5-Xylenol is not readily biodegradable (2% after 28 d, OECD 301C). In a study similar to OECD guideline 302B conducted with adapted activated sludge as inoculum, a COD removal of 94.5% was determined after 5 days of incubation. Because of the use of adapted sludge, the substance is assessed as inherently biodegradable, not fulfilling specific criteria.

Thus, the test substance is considered to be potentially P or vP.

Bioaccumulation

The log Pow determined for 2,5-Xylenol is 2.6 at 25 °C and pH3 (undissociated form; OECD TG 117). The pKa of 10.41 indicates that the substance mainly exists in the undissociated form at environmentally relevant pH values (pH 4-9).

Thus, the substance is not B or vB.

Toxicity

All available acute and chronic effect concentrations are > 0.01 mg/L. Furthermore, the substance is not classified as carcinogenic, or mutagenic, or toxic for reproduction according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs). Therefore, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and it is concluded that the substance is not T.

In conclusion, the substance is not PBT/vPvB.